Lead Engineer, Equipment Qualification & Validation

Bristol-Myers Squibb; Summit (NJ); On-site; USD 88,000 - 107,000; Full time

Benefits offered by this job

Health coverage

401(k) plan

Paid time off

Stock opportunities

Job summary

Bristol Myers Squibb in Summit, NJ, is seeking a Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery to manage commissioning and qualification projects for new equipment, utilities, and facilities at multi-use sites. You will collaborate with internal stakeholders and external vendors to ensure timely, compliant execution.

The role emphasizes project leadership, regulatory compliance (cGMP, 21 CFR 11), and delivering validated systems.

Qualifications

• Knowledge of cGMP, GXP, GAMP, SDLC regulations and 21 CFR 11.
• Experience with qualification/validation in pharmaceutical manufacturing.
• Strong written and verbal communication skills.

Responsibilities

• Lead commissioning and qualification activities for equipment, utilities and facilities.
• Develop qualification protocols and reports.
• Supervise vendors and contract project teams to ensure compliance and on-time delivery.
• Maintain documentation in accordance with BMS standards.

Skills

cGMP

GXP

GAMP

21CFR Part 11

Qualification/Validation

Documentation

Project Management

Communication

Multitasking

Microsoft Office

Education

BS in Engineering or Science

Tools

Microsoft Office Suite

Job description

Bristol Myers Squibb in Summit, NJ, is seeking a Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery to manage commissioning and qualification projects for new equipment, utilities, and facilities at multi-use sites. You will collaborate with internal stakeholders and external vendors to ensure timely, compliant execution.

The role emphasizes project leadership, regulatory compliance (cGMP, 21 CFR 11), and delivering validated systems.